GXQ — Dura Substitute Class II
FDA Device Classification
Classification Details
- Product Code
- GXQ
- Device Class
- Class II
- Regulation Number
- 882.5910
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K251191 | collagen matrix | Collagen Dura Regeneration Membrane - Repair | November 18, 2025 |
| K250420 | helios biomedical | Helios Dura Regeneration Matrix | May 14, 2025 |
| K223445 | nurami medical | ArtiFascia | August 10, 2023 |
| K212943 | synthes (usa) products | SyntheCel Dura Repair | January 28, 2022 |
| K183513 | lemaitre vascular | XenoSure Dura Biologic Patch | June 13, 2019 |
| K172603 | acera surgical | Cerafix Dura Substitute | November 27, 2017 |
| K163456 | integra lifesciences corporation | DuraGen Secure Dural Regeneration Matrix | January 6, 2017 |
| K161370 | medtronic neurosurgery | Durepair Dura Regeneration Matrix | November 2, 2016 |
| K161278 | acera surgical | Cerafix Dura Substitute | August 8, 2016 |
| K153613 | acera surgical | Cerafix Dura Substitute | March 16, 2016 |
| K150825 | collagen matrix | Collagen Dural Regeneration Matrix | November 20, 2015 |
| K152481 | codman and shurtleff | DURAFORM Dural Graft Implant | October 30, 2015 |
| K141608 | collagen matrix | COLLAGEN DURA MEMBRANE | January 16, 2015 |
| K132850 | rti surgical | BOVINE PERICARDIUM SUTURABLE DURAL GRAFT, TUTOPATCH DM GRAFT, TUTOPLAST BOVINE P | March 31, 2014 |
| K131792 | synthes | SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAY | December 16, 2013 |
| K131015 | cook biotech | BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT | October 8, 2013 |
| K122791 | aesculap | LYOPLANT ONLAY | June 4, 2013 |
| K120600 | integra life sciences | DURAGEN SECURE DURAL REGNERATION MATRIX | June 15, 2012 |
| K113071 | synthes | SYNTHECEL DURA REPLACEMENT DEVICES | January 9, 2012 |
| K092388 | integra lifesciences corporation | DURAGEN PLUS DURAL REGENERATION MATRIX- SPINAL MATRIX, MODEL DP2013SM, INTEGRA S | January 21, 2010 |